Office of Orphan Products Development (OOPD) is pleased to announce the recipients of the Pediatric Device Consortia Grant Program Awards for 2013. The recipients are as follows:
- University of Michigan Pediatric Device Consortium, led by James Geiger, M.D., $700,000/ year
- Atlantic Pediatric Device Consortium, led by David Ku, M.D., Ph.D., $700,000/ year
- National Capital Consortium for Pediatric Device Innovation, led by
Peter Kim, M.D., Ph.D , $700,000/ year
- New England Pediatric Device Consortium, led by Rick Greenwald, Ph.D., $700,000/ year
- Southern California Center for Technology and Innovation in Pediatrics, led by Yaniv Bar-Cohen, M.D., $300,000 /year
- Philadelphia Regional Pediatric Medical Device Consortium, led by
Matthew Maltese, M.S., Ph.D., $300,000/year
- Boston Pediatric Device Consortium, led by Pedro del Nido, M.D., $200,000/year
This is the third time since 2009 that FDA has awarded grants to consortia which advance the development of pediatric medical devices. This year’s awards will be granted to consortia that each bring together teams with excellence and expertise in delivering business, regulatory, legal, scientific, engineering, and clinical services for children.
In addition to business and regulatory advising, the consortia’s device development services include intellectual property advising, prototyping, engineering, laboratory and animal testing, grant writing, and clinical trial design.
These consortia will support pediatric medical device progression through all stages of developmentâ€”concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization. At each stage the consortia will assess and provide meaningful feedback about the scientific and medical merit of proposed pediatric device projects. The consortia will provide advice on Federal and non-Federal funding resources.
Along the way, the consortia will work collaboratively with the Food and Drug Administration to help innovators effectively navigate existing laws, regulations, and agency guidance to protect the health and safety of children.